Audit Trail Filters

Users can apply additional filters to the selected parameter. The following filters are available in the Audit Trail modal, allowing users to retrieve specific data.



Actions Taken: This dropdown displays a list of actions to be selected from the dropdown menu for filtering the audit trail as per the selected parameter. The Actions Taken dropdown populates and displays actions depending upon the parameter selected. Users can either select all actions or select specific actions by clicking on their respective checkboxes.



Parameter Actions Taken
eTMF Documents
  • Certify Documents
  • Delete Attachment
  • Delete Document
  • Move Document to Folder
  • Metadata Update
  • Lock Document Profile
  • New Attachment
  • New Document Profile
  • Open Document
  • Open Document Metadata
  • QC Workflow – Approve Document
  • QC Workflow – Claim Document
  • QC Workflow – Clarification
  • QC Workflow – Reassign
  • QC Workflow – Release Document
  • QC Workflow – Swim Lane
  • Query – Create Query
  • Query – Respond to Query
  • Query – Update Query
  • Replace Attachment
  • Security Update
  • Send eSignature Request
  • Send Mail
  • Unlock Document Profile
Start-Up Documents
  • Delete Document
  • Move Document to Folder
  • Metadata Update
  • New Attachment
  • New Document Profile
  • Not Applicable
  • Open Document
  • Open Document Metadata
  • SSU – New Essential Document
  • SSU – QC Review
  • SSU – Regulatory Review
  • SSU – Sponsor Review

Start-Up and eTMF Documents

  • Certify Documents
  • Delete Attachment
  • Delete Document
  • Move Document to Folder
  • Metadata Update
  • Lock Document Profile
  • New Attachment
  • New Document Profile
  • Not Applicable
  • Open Document
  • Open Document Metadata
  • QC Workflow – Approve Document
  • QC Workflow – Claim Document
  • QC Workflow – Clarification
  • QC Workflow – Reassign
  • QC Workflow – Release Document
  • QC Workflow – Swim Lane
  • Query – Create Query
  • Query – Respond to Query
  • Query – Update Query
  • Replace Attachment
  • Security Update
  • Send eSignature Request
  • Send Mail
  • SSU – New Essential Document
  • SSU – QC Review
  • SSU – Regulatory Review
  • SSU – Sponsor Review
  • Unlock Document Profile
Folder
  • Edit Folder
  • Metadata Update
  • Check Out
  • New Folder
  • Open Folder Profile
  • Security Update
  • Check In
Placeholder
  • Delete Placeholder
  • Metadata Update
  • New Placeholder
  • Security Update
Users
  • Add to Contacts
  • Add User as Contact
  • Add User to Group
  • Assign Group Actions to User
  • Assign User Actions
  • Edit User
  • New User
  • Remove from Contacts
  • Remove Study Site Contact
  • Remove User from Group
  • Sign In to Room
  • User Access Level Update
  • User Invitation
  1. Select Created By: In the Select Created By field, users can specify one or more usernames associated with document creation in eTMF. When a username is selected, the Audit Trail screen filters and displays records corresponding to the specified user.


  2. Date Filters: Users must enter start and end dates in their respective fields to search for a document. By default, the start date is set to the previous month, and the end date is set to today. To select dates, click on the calendar icon. Once the dates are chosen, click the Apply button on the right side to view the search results. Users can also select dates from the previous year by scrolling up in the Months field.


  3. Document ID Filter: The Document ID field allows users to retrieve audit trial for a specific document by entering its ID number, separated by commas. After entering the document ID, users must click the Apply button on the right side to view the search results


  4. Note: The Document ID Filter is applicable only for eTMF Documents, Start-Up Documents and Start-Up and eTMF Documents.

  5. Select Folders: The Select Folders field allows users to specify certain folders and retrieve the audit trail for those specified folders.
    1. Select Folders as the parameter.
    2. Click on the Select Folders button.
    3. On the Select Folders screen, expand the desired category and select the folder.
    4. Toggle on the Show Empty Folders switch to display empty folders.
    5. Enable the Automatically Check Subfolders toggle switch to automatically select folders associated with the parent category.
    6. To search for a specific folder, enter the search term in the Search box.
    7. Click on the Select button.


  6. Placeholder ID: The Placeholder ID field allows users to retrieve audit trial for a specific placeholder by entering its ID number, separated by commas. After entering the placeholder ID, users must click the Apply button on the right side to view the search results.


  7. All Users: The All Users filed allows users to retrieve audit trail for specific users by entering multiple user names. After specifying user names, users must click the Apply button on the right side to view the search results.


  8. Refresh: The Refresh button is visible and accessible when the audit trail results are displayed. When a parameter or a filter is updated, users need to click the Refresh button to update the audit trail records as per the newly applied filters and parameters.